Spinal surgery distraction with an integrated retractor

ABSTRACT

A spinal surgery retractor and method of use. The retractor includes a slotted keyway for integrating a keyed spinal distractor. The retractor and distractor combination slide together to displace a portion of the intervertebral disk space to restore or maintain intervertebral spacing and facilitate retraction of surrounding soft tissues while disk space surgery is performed. The distractor head and mating portion of the retractors have matching profiles that enable the retractor to maintain distraction of the vertebra after removal of the distractor portion of the tool, permitting access to increase at the operating site.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.13/335,273 filed Dec. 22, 2011, which is a continuation of U.S.application Ser. No. 11/163,018 tiled Oct. 3, 2005, which issued as U.S.Pat. No. 8,105,331. The contents of each of these applications areincorporated by reference herein in their entireties for all purposes.

BACKGROUND OF THE INVENTION

1. Field of Invention

This invention generally relates to the field of surgical appliances fordisk space spinal surgery, specifically retractors and distractors thatare used to facilitate retraction of soft tissue surrounding the discspace, and the management intervertebral spacing in disc space surgerywith a distraction device.

2. Prior Art

Surgery involving spinal disc space operations that require open accessthrough an incision usually necessitate a means to hold the incisionopen without injury to retracted tissue while the surgeon operates onthe diseased or injured portion of the spine. This retraction reducesthe required size of the surgical incision, contributing to improvedvisualization of pathology, while decreasing surgical risk factors. Inaddition to this, disc space surgical procedures often require a meansto stabilize and maintain intervertebral spacing via a distractiondevice for the disc space being operated on.

Few retractors used in disk space surgery incorporate a distractiondevice to maintain intervertebral spacing. Those that do, incorporate adistractor that is usually cumbersome, and bulky and often requiresdrilling. One example of a device of similar function is theretractor-distractor device within U.S. Pat. No. 5,944,658. Like thisexample, most spinal retractors for open access surgery that incorporatea distractor are typically complex, awkward, time consuming to set up,and are usually comparatively difficult work with when there is a needto quickly modify apparatus position, distraction within new position,and degree of retraction, when compared to dedicated devices.

OBJECTS AND ADVANTAGES OF THE INVENTION

The present invention offers several advantages over existing devicesused in the art. Some of these advantages are:

(a) The present invention enables the direct placement of a retractorattached to a distractor to maintain soft tissue distraction without theneed for an individual holding the retractor blade and maintainingpressure on the soft tissues. This provides the surgeon with enhancedcontrol of the soft tissue retraction process, thereby reducing thechances of necrosis of the soft tissue.

(b) The distractor retractor assembly also reduces the chances of softtissue coming out from underneath the retractor due to the fact that aportion of the retractor extends down into the disk space. This isparticularly important, as once portions of the vertebral disk have beenremoved, the resulting void presents a space for soft tissue such asblood vessels and nerves to enter, increasing the chances for softtissue damage during final removal of disk space material and/orplacement of implants, i.e., total disk replacements or vertebralinterbody fusions.

(c) The ability to have a retractor which has a proximal flexibleportion, allowing one to bend this portion of the retractor away fromthe operating field, resulting in an increase of the amount of exposureand light that can be brought into the operating field, improving thequality of the exposure. Everything that can be done to improve thequality of operating field exposure with less risk to the soft tissueminimizes the overall risks of the surgery.

(d) The integration of a distractor head with the retractor allows formaintenance of the disk height during removal of the disk material,which tends to collapse as the disk material is removed. This ispossible since successive replacement of the distraction portion of theassembly is enabled via the keyway and slot on the retractor. Thischaracteristic of the invention aids in the gradual progression ofdistraction. Thus, providing control of distraction while giving a muchbetter visualization of the soft tissue within the disk as well asimproving access for the removal of any disk herniated fragments frombehind the disk space.

(e) Surgical distraction of vertebra and retraction of adjacent softtissue can be maintained by the retractor after the distractorintegrated with its retractor has accomplished initial distraction. Thusallowing subsequent removal of the distractor tool from the retractorkeyway and the operating site after the initial distraction. Thisprovides retraction with a comparative increase in access to theoperating site when distraction and retraction are coincident surgicalrequirements. This can be followed with incremental distraction changesby exchanging the distractor portion of the assembly and/or alternatelychanging distractor-retractor assemblies laterally.

Further advantages will become apparent from a consideration of thefollowing description and drawings.

SUMMARY OF THE INVENTION

The present invention is broadly directed toward a spinal distractorthat is combined with a retractor, for use in lumbar, thoracic, andcervical disc space surgery. At this time, the preferred usage of theinvention involves lumbar spine surgical procedures of the disk spaceand vertebral distraction at the L5-S1, L3-L4, and L2-L3 levels via aretroperitoneal approach anteriorly with retraction of adjacent softtissue.

The present invention consists of two major parts of an integratedassembly that is used as a spinal surgery retractor and distractor. Thedistractor portion of the invention has a distractor head or plugincorporating a keyed shape on its face that mates to a portion of theretractor via a keyway in the distal end of the retractor. This matingportion of the retractor has a profile that matches or is similar to theprofile of the distractor head. The distractor head has a rod fastenedto it, preferably using machine screw threads that provide a means toapply insertion force to the entire assembly, and removal force to thedistractor portion of the assembly.

Once the distractor is engaged with the retractor through its keyway,the shape of the retractor keyway does not allow the distractor to slideahead of the retractor. This enables the distractor to apply insertionforce to the entire assembly to enable progression into the incision,followed by insertion of the distal tip of the entire assembly into aportion of the disc space, with most or all of the insertion forceapplied to the distractor.

A slot adjacent to the retractor keyway enables removal of thedistractor from the retractor after insertion of the assembly into theoperating site, allowing for an increase of exposure in the operatingfield, and for minute changes in distraction by exchanging thedistraction portion of the assembly. After the assembled distractor andretractor are inserted into the operating site, the retractor can beused to maintain distraction at the operating site by employing itsdistal end profile (described above).

The retractor has a thinned or blade shaped proximal end to allow forflexibility of its proximal portion, enabling further progression ofretraction and permitting increased access to the operating field. Inaddition, the retractor has convex curved surfaces that interface with asignificant amount of retracted soft tissue during progression of theretraction process, which contributes towards retractor safety. Theportion of the retractor tool described above as ‘thinned or bladeshaped’, is formed at the opened end of the above-described slot byabruptly tapering to a uniform thickness which extends uniformly to theproximal edge of the surgical tool.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows the distractor tool combined with the retractor, with thelengthwise edge of the retractor exposed.

FIG. 2 shows the retractor without its distractor, with the keyway,matching profile and slot adjacent to the keyway exposed with referencenumber 10.

FIG. 3 shows the retractor with corresponding reference numerals.

FIG. 4 shows an orthogonal top view of the retractor with hidden linesillustrating the extent of the distal end keyway and portions of thesoft-tissue-interfacing convex surfaces.

FIG. 5 is a cross sectional view of the distal tip of the retractor,showing one orthogonal view pointing into the retractor keyway.

FIG. 6 is a cross sectional view of the distal portion of convexsurfaces on the retractor and orthogonal view pointing into the slotthat is adjacent to the keyway.

FIG. 7 is a cross sectional view of the middle portion of the convexsurfaces on the retractor and the middle of the slot that is adjacent tothe keyway.

FIG. 8 shows the distractor head and distractor rod separated, withhidden lines illustrating the extent of the keyed portion of thedistractor head and machine screw threads on the distractor rod.

FIG. 9 shows an orthogonal view of the distractor head with the matchingprofile and keyed portion facing out.

FIG. 10 shows an orthogonal view of the side of the distractor head witha side view of the keyed portion of the distractor.

FIG. 11 shows an orthogonal view of the distal end of the distractorhead.

FIG. 12 is a top view of the retractor, distractor head, and distractorrod, with the direction of placement indicated for integration.

FIG. 13 is a side view of the spine with the distal tip of the retractorinserted in the disc space, with ‘V’ indicating vertebra and ‘D’indicating the intervertebral disc.

DRAWINGS Reference Numerals

Description of elements 1-12: 1 retractor; 2 distractor head; 3distractor rod; 4 retractor distal tip; 5 flexible section of retractor;6 taper to flexible section; 7 retractor convex curves; 8 retractorkeyway; 9 starting point of retractor; 10 slot adjacent to keywaymatching-profile; 11 keyed portion of the distractor head; and 12 endpoint-matching profile,

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

The preferred embodiment of the present invention with all its partsintegrated is illustrated in FIG. 1. Within this figure the retractor 1is shown with the distractor head 2 engaged with the distal tip of theretractor 4 (shown in proportion with a 14 mm wide distal tip). Thedistractor head 2 is fastened together with distractor rod 3 withmachine screw threads. With the distractor portion of the assemblyremoved as shown in FIG. 2, the slot 10 of the retractor portion of theinvention that enables removal of the distractor head is visible.

Similarly, FIG. 3 details other features of the retractor that arevisible when the distractor portion of the assembly is removed. Thedetail shown in FIG. 3 illustrates the distal tip of the retractor,which has a profile that matches the profile of the distractor head, andis indicated as feature reference 4 (shown in proportion with a 14 mmwide profile). This feature incorporates the retractor keyway 8 on theface that mates with the distractor head 2 {shown in FIG. 1}. The keyway8 extends and opens to the slot 10 shown on FIG. 2.

Continuing further from the distal tip and on the broad side opposite ofthe slot 10 (FIG. 2) of the retractor as shown in FIG. 3, is a featurereferenced as 7, which shows the convex surfaces that interface withsoft tissue. In FIG. 3 shown, indicated by feature reference number 6 isan abrupt taper. This taper ends at the feature referenced as 5,resulting in a usable flexibility of the proximal portion that is shownas feature 5 within FIG. 3. Feature 5 has been previously described inthe summary as ‘thinned or blade shaped’ and thus, the retractor portionof the assembly can be alternately described as a retractor blade,although it is much more intricate and functional than a simple bladestructure.

FIG. 4 also illustrates a view of the retractor (retractor bladestructure) without the distractor portion of the assembly. This view ofthe retractor shows the extent of the distal tip of the retractor, whichincorporates the profile that matches the distractor head profile (FIGS.1 and 8 ref. #2) using feature reference numbers 9 and 12 as limits.This view of the distal tip of the retractor also shows the extent ofthe hidden portion of the keyway between feature reference numbers 9 and12 (shown in proportion with a 14 mm wide distal tip profile). Inaddition, FIG. 4 also references cross sections of the retractordepicted in FIGS. 5, 6, and 7.

The illustration in FIG. 5 shows an enlarged view of the cross sectionof the distal tip of the retractor. This figure shows the crosssectional shape of the retractor keyway 8. Additionally, the keyway 8sectional view in FIG. 5 shows a beveled shape, which enables the keyway8 to retain the distractor head 2 {shown in FIG. 1} when its keyed faceis slid into the retractor keyway 8.

The cross section of the distal portion of the slot adjacent to theretractor keyway (top of illustration) and the distal convexly curvedsurfaces (bottom of illustration) that interface with soft tissue—areshown in FIG. 6. The middle cross section of the same type of surfacesis shown in FIG. 7.

An orthogonal view of the distractor head with the matching profile andkeyed section facing out is illustrated in FIG. 9. The hidden lineswithin this figure show the interface of the keyed section of thedistractor head and its matching profile, as well as an example of theextent of the distractor rod fastening hole. Also note that the distalend of the keyed section (shown in FIG. 9) is round and matches thedistal end of the retractor keyway 8. This feature creates an interface,that when slid together with the retractor keyway, prevents thedistractor from sliding in advance of the retractor. FIGS. 10 and 11 areorthogonal views from the side and distal end of the distractor headwith further detail of the keyed section.

The organization of the complete assembly is illustrated in FIG. 12. Asshown in this figure, the distractor rod 3 is fastened to the distractorhead 2 and this distractor tool assembly is slid into the retractor inthe direction indicated until the retractor keyway stops the slidingaction with its closed curved end (feature reference 8).

Operation of Invention

The operation of the invention is described in the following paragraphin part referring to the abbreviated illustration in FIG. 13, whichshows the lumbar spine and the retractor, with “D” indicatingintervertebral disks and “V” indicating lumbar vertebra. The preferredapplication of the invention is detailed as follows:

The primary surgical procedures anticipated to utilize the invention atthis time involve the lumbar spine, especially those concerningdiskectomies at the L5-S1, L4-L5, 1-3-L4, and L2-L3 levels via aretroperitoneal approach anteriorly with retraction (Refer to FIG. 13).In reference to the most anticipated utilization, bilateral placement ofthe retractors (blades) is suggested, with placement to be as far to oneside of the other initially as possible, after insertion of thedistractor-retractor assemblies and subsequent initial removal of thedistractors. This allows for maximal exposure to disk space whileworking on the other side.

It is preferred to initially remove some of the inner nucleus pulposusprior to insertion of the retractor/distractor assembly and initialdistraction of the disk space, thereby eliminating the risk of pushingmaterial into the spinal canal. In addition, during placement of thedistractors in the disk space, it is also part of the preferred methodto minimize the possibility of over distraction of the disk space, bydistracting in a graduated fashion rather than trying to bring the diskspace up to its maximal size immediately.

Generally, for the lumbar region, I would recommend starting out with an8 mm distractor head with matching retractor initially, and thengradually increasing to the size desired via procedurally alternatingthe removal and insertion of retractor-distractor assemblies laterally.Coincident with these procedures, one must be careful when dealing withosteoporotic bone, so that one does not over distract, since this mightcreate some risk of compression fractures or making divots in the bonewhich can make future placement of implants within the disk-spacedifficult. After the desired distraction is achieved, the distal tip ofthe retractor is left in the disk space during the remainder theoperation allowing it to maintain distraction while providing a meansfor retraction (FIG. 13).

When the desired distraction is achieved with the distractor-retractorassembly, the progression of retraction may be continued or maintainedwith the flexible portion of the retractor while distraction is beingmaintained with the matching profile of the distal tip of the retractor.

Future Revisions

Anticipated revisions that are conceptual extensions of the abovedescribed preferred embodiment include, but are not limited to; anassembly that has distractor rod diameter and length changes, othermethods of fastening the distractor head to the rod, changes in thevariation of convexly curved surfaces (soft tissue interface), curvemodifications to distractor head and retractor matching profiles, andsize modifications involving differing proportions of several aspects ofthe assembly to enable use for posterior to anterior procedures from thelumbar to cervical regions of the spine. Additional possible revisionsare listed as follows:

1. The thin flexible blade-like portion of the tool may beproportionally increased in length, while correspondingly shorteningother prominent features like the keyway slot and its opposing surfacesto enable better use in other regions of the spine.

2. Distractor head surfaces may be modified with rasp surfaces to enablepreparation of vertebral endplates for various implants and grafts forspinal fusion or disk replacements.

3. Distractor head matching profile available with differing thicknessto enhance or augment other distractor head features.

3. Distractor head and distal tip of retractor modified to include alight source for better visualization of the operating field.

4. The shape of the retractor and/or distractor may be modified withformed or rectangular sections to accept commonly used implants andgrafts for spinal fusion or disk replacement.

5. Retractor changes in the curvature surrounding the blade and theamount of the retractor which is solid versus flexible (thinnedsection).

6. Radio opacity to enable x-ray imaging while portions of the assemblyare left in the operating site.

Future possible revisions will offer marked increases in the functionand utility of the present invention over and above the currentpreferred embodiment. This is significant, considering that the currentpreferred embodiment offers important advantages in the surgical arenasuch as:

1. The direct placement of a retractor attached to a distractor tomaintain soft tissue retraction without the need for an individualholding the retractor blade and maintaining pressure on the softtissues, which provides the surgeon with additional control of the softtissue retraction process.

2. A distractor retractor assembly that reduces the chances of softtissue coming out from underneath the retractor due to the fact that aportion of the retractor extends down into the disk space. This isparticularly important, since the migration of the soft tissue duringspinal surgery should be minimized, since it could increase the chancesfor soft tissue damage during final removal of disk space materialand/or placement of implants.

3. A retractor which has a proximal flexible portion, allowing one tobend this portion of the retractor away from the operating field,resulting in an increase of the amount of visual exposure and light thatcan be brought into the operating field, resulting in improved qualityof the visual exposure at the operating site.

4. The integration of a distractor head with a retractor to providemaintenance of the disk height during removal of the disk material,which tends to collapse as the disk material is removed. This ispossible since successive replacement of the distraction portion of theassembly is enabled via the keyway and slot on the retractor. Thischaracteristic of the invention aids in the gradual progression ofdistraction in addition to allowing for greater visibility, thusimproving access for the removal of any disk herniated fragments frombehind the disk space.

5. Surgical distraction of vertebra and retraction of adjacent softtissue can be maintained by the retractor after the distractorintegrated with its retractor has accomplished initial distraction. Thusallowing subsequent removal of the distractor tool from the retractorkeyway and the operating site after the initial distraction, providingretraction with a comparative increase in access to the operating sitewhen distraction and retraction are coincident surgical requirements.

These are not the only conceivable advantages that the currentembodiment offers, since the unique nature of the having a keyeddistractor head attached to a rod, which offers the option to beintegrated with a retractor—can offer other advantages based on emergingprocedures that may call for its use.

In summary, when the preferred embodiment of the invention is utilized,it provides for the complete removal of the disk, removal of thevertebral cartilagonous end-plates in a safe fashion—protecting the softtissue surrounding the disk, as well as maintaining distraction of thedisk space, allowing one to do the most complete removal of the diskspace and fragments that have herniated behind the vertebral body.

What is claimed is:
 1. A method of assembling a distractor retractorassembly, the method comprising: securing a distractor rod to a proximalend of a distractor head, wherein a distal end of the distractor headhas a tapered profile between the distal end and the proximal endconstructed and arranged for insertion between adjacent vertebralbodies, the distal head includes a plurality of side faces positionedbetween the distal end and the proximal end, and a keyed shapedprojection is secured to one of the side faces; and engaging thedistractor head on a distal tip of a retractor, the distal tip beingconstructed and arranged for insertion between adjacent vertebralbodies, the distal tip of the retractor including a keyway having abeveled shape and the keyed shaped projection of the distractor head hasa profile which is constructed and arranged to engage and cooperate withthe keyway to operatively connect the distractor head to the retractor.2. The method of claim 1, wherein engaging the distractor head on thedistal tip of the retractor includes sliding the distractor head ontothe retractor until the keyway stops the sliding action.
 3. The methodof claim 1, wherein the distractor rod enables an insertion force to beapplied to the distractor head and thereby an insertion force applied tothe retractor through the keyway.
 4. The method of claim 3, wherein thekeyway has a closed shape at its distal end, whereby the closed shapeprevents the keyed distractor head from sliding in advance of theretractor when both the distractor head and the retractor are insertedtogether into an operating site.
 5. The method of claim 4, wherein thekeyway prevents the distractor head from separating from the retractorwhen both the distractor head and retractor are inserted together intothe operating site with the insertion force applied to the distractorhead.
 6. The method of claim 1 further comprising removing thedistractor head, wherein the distractor rod enables a removal force tobe applied to the distractor head and thereby remove the distractor headfrom the keyway.
 7. A method of using a distractor retractor assembly inspinal surgery, the method comprising: providing a distractor retractorassembly including a distractor portion and a retractor portion, thedistractor portion including a distractor head and a distractor rod, thedistractor head having a distal end and a proximal end, a keyed shapedprojection secured to the distractor retractor assembly, a distal tip ofthe retractor portion including a keyway having a beveled shape, thekeyed shaped projection of the distractor head having a profile which isconstructed and arranged to engage and cooperate with the keyway tooperatively connect the distractor retractor assembly between adjacentverterbral bodies; and inserting the distractor retractor assembly intoa disc space between adjacent vertebral bodies.
 8. The method of claim7, wherein the distractor retractor assembly is configured to retractsoft tissue surround the disc space.
 9. The method of claim 7, whereinthe retractor portion and the distractor portion are inserted togetherinto the disc space.
 10. The method of claim 7, wherein after insertingthe distractor portion into the disc space, subsequently, removing thedistractor portion.
 11. The method of claim 7 further comprisingremoving a portion of inner nucleus pulposus before inserting thedistractor retractor assembly into the disc space.
 12. The method ofclaim 7, wherein the distractor retractor assembly is inserted into thedisc space in a graduated fashion in order to minimize over distractionof the disc space.
 13. The method of claim 7, wherein the retractorportion is substantially the same length as the distractor portion. 14.A method of using a distractor retractor assembly in spinal surgery, themethod comprising: securing a distractor rod to a proximal end of adistractor head, wherein a distal end of the distractor head has atapered profile between the distal end and the proximal end constructedand arranged for insertion between adjacent vertebral bodies, the distalhead includes a plurality of side faces positioned between the distalend and the proximal end, and a keyed shaped projection is secured toone of the side faces; and engaging the distractor head on a distal tipof a retractor, the distal tip being constructed and arranged forinsertion between adjacent vertebral bodies, the distal tip of theretractor including a keyway having a beveled shape and the keyed shapedprojection of the distractor head has a profile which is constructed andarranged to engage and cooperate with the keyway to operatively connectthe distractor head to the retractor; and inserting the distractor headinto a disc space between adjacent vertebral bodies.
 15. The method ofclaim 14 further comprising bending a proximal flexible portion of theretractor to increase an amount of visual exposure and light to anoperating field.
 16. The method of claim 14, wherein engaging thedistractor head on the distal tip of the retractor includes sliding thedistractor head onto the retractor until the keyway stops the slidingaction.
 17. The method of claim 14, wherein the distractor rod enablesan insertion force to be applied to the distractor head and thereby aninsertion force applied to the retractor through the keyway,
 18. Themethod of claim 17, wherein the keyway has a closed shape at its distalend, whereby the closed shape prevents the keyed distractor head fromsliding in advance of the retractor when both the distractor head andthe retractor are inserted together into an operating site.
 19. Themethod of claim 18, wherein the keyway prevents the distractor head fromseparating from the retractor when both the distractor head andretractor are inserted together into the operating site with theinsertion force applied to the distractor head.
 20. The method of claim14 further comprising removing the distractor head, wherein thedistractor rod enables a removal force to be applied to the distractorhead and thereby remove the distractor head from the keyway.